UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055981 |
|---|---|
| Receipt number | R000063983 |
| Scientific Title | Non-invasive Measurement Pancreatic Juice Flow Rate and Production Using MRI |
| Date of disclosure of the study information | 2024/11/01 |
| Last modified on | 2025/09/03 22:40:56 |
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Basic information
Public title
Non-invasive Measurement Pancreatic Juice Flow Rate and Production Using MRI
Acronym
Non-invasive Measurement Pancreatic Juice Flow Rate and Production Using MRI
Scientific Title
Non-invasive Measurement Pancreatic Juice Flow Rate and Production Using MRI
Scientific Title:Acronym
Non-invasive Measurement Pancreatic Juice Flow Rate and Production Using MRI
Region
| Japan |
Condition
Condition
Chronic pancreatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We conducted imaging using VENC 3D T2WI, a novel sequence developed by our team, to observe and evaluate the flow rate and production of pancreatic juice in patients presenting with abdominal symptoms or abdominal diseases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Values of Pancreatic Juice Flow Rate and Production Obtained Using the VENC 3D T2WI sequence
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
We aim to perform imaging using the VENC 3D T2WI sequence on patients scheduled for abdominal MRI examinations. Based on the acquired image data, we will measure the flow rate and production of pancreatic juice.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Outpatients of Keio University Hospital who present with abdominal diseases or symptoms and are scheduled for an abdominal MRI examination.
Key exclusion criteria
1. Individuals under 20 years of age
2. Pregnant individuals or those with a potential for pregnancy
3. Individuals with electrically, magnetically, or mechanically operated implanted devices (such as pacemakers)
4. Individuals who are considered intolerant to prolonged imaging due to conditions such as claustrophobia
5. Other individuals deemed unsuitable by the principal or co-investigators
Target sample size
393
Research contact person
Name of lead principal investigator
| 1st name | Taiki |
| Middle name | |
| Last name | Nozaki |
Organization
Keio University, School of Medicine
Division name
Department of Radiology
Zip code
160-8582
Address
Shinanomachi 35, Shinjuku, Tokyo, Japan
TEL
0353633837
nozaki@rad.med.keio.ac.jp
Public contact
Name of contact person
| 1st name | Taiki |
| Middle name | |
| Last name | Nozaki |
Organization
Keio University, School of Medicine
Division name
Department of Radiology
Zip code
1608582
Address
Shinanomachi 35, Shinjuku, Tokyo, Japan
TEL
0353633837
Homepage URL
nozaki@rad.med.keio.ac.jp
Sponsor or person
Institute
Department of Radiology, Keio University, School of Medicine
Taiki Nozaki
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University, School of Medicine
Address
Shinanomachi 35, Shinjuku, Tokyo, Japan
Tel
0333531211
keio@esct.bvits.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 10 | Month | 29 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 29 | Day |
Last modified on
| 2025 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063983
